In a previous post, we discussed FDA's request for comments on "Listing of Patent Information in the Orange Book" in online public Docket FDA-2020-N-1127. In that request, FDA sought comments as part of its effort to modernize the Orange Book on the type of patent information listed in the Orange Book. Comments were accepted from June 1, 2020 through August 31, 2020, electronically and in writing.

Specifically, FDA requested comments on the submission and listing of certain patents, including:

  1. patents claiming a device constituent part of a combination product approved under section 505 of the FD&C Act;
  2. patents that claim a device whose use is referenced in approved drug labeling;
  3. patents associated with an established Risk Evaluation Mitigation Strategy ("REMS"); and
  4. patents associated with digital applications.

Simultaneously, FDA opened Dockets FDA-2020-D-1068 and FDA-2020-N-1069, requesting comments on a draft guidance titled "Orange Book – Questions and Answers" as well as on how stakeholders and the public use the Orange Book and how it can be improved to make sure the published information is clear and helpful.1 The Appendix to the Intellectual Property Owners Association ("IPO") report specifically addresses such improvements on the Orange Book and focuses on listing Form 3542.

For Docket FDA 2020-N-1127, 17 comments were submitted. A complete list of the submitting parties is found below.2 As is evident, comments came from diverse groups, such as (1) trade associations, including PhRMA, BIO, and IPO, (2) brand name pharmaceutical companies, including Sanofi and Novo Nordisk, (3) generic manufacturers, including Apotex, and Mylan, and (4) academics.

Finnegan contributed to the IPO response relating to Docket FDA 2020-N-1127. IPO commented that device-related patents, REMS-related patents, and patents associated with digital applications should be listed in the Orange Book as long as a claim of patent infringement could reasonably be asserted. See IPO Response at pp. 5-7. In particular, IPO believes that FDA should maintain its ministerial role for Orange Book listings, leaving it to the NDA applicant to determine whether patents sought to be listed meet statutory requirements and corresponding regulations for Orange Book listing. See id. at p. 6.

Similarly, a number of stakeholders, including brand-name pharmaceutical companies and organizations supporting thereof, opined that device-related patents, REMS-related patents, and patents associated with digital applications should not be categorically restricted or excluded from the Orange Book listing. These stakeholders expressed that patents claiming a device constituent of an NDA-approved drug-device combination product or a component thereof ? including patents that do not disclose or claim the active ingredient or formulation of the approved drug product ? meet the listing standard, consistent with the current industry practice. See, e.g., PhRMA Response at pp. 7, 8, and 14-16;3 BIO Response at pp. 5, 6, and 10;4 Sanofi Response at pp. 3-5 and 15;5 Novo Nordisk at pp. 7 and 9.6 That same opinion was expressed with regard to patents claiming a method of using such a constituent device or component thereof. Id. At least two commenters supported listing REMS-related patents and patents for digital applications when statutory and regulatory criteria, e.g., 21 C.F.R. 314.53, are deemed to be met by the NDA holder. See, e.g., PhRMA Response at pp. 17 and 18 and BIO Response at pp. 11-13.

On the other hand, other responses, including some from generic drug companies, opposed listing device-related patents broadly. Their comments proposed that a patent that claims an integrated device component of a drug-device combination product cannot be listed unless it expressly discloses the NDA product by name, its API by name, or its precise formulation; the integrated device component of the product necessarily must be disclosed in the approved NDA product labeling to qualify for listing in the Orange Book; or the underlying device itself be labeled for use with the specific NDA product in order to qualify for listing. See e.g., Civica Response at p. 5; Mylan Response at p. 5; Apotex Response at pp. 4-6. Additionally, some comments asserted that REMS-related patents should not be listed in the Orange Book because they do not "claim" the approved drug or a method of using such drug. See Civica Response at pp. 4 and 5; Mylan Response at p. 3; Apotex Response at p. 7.

As such, brand and generic manufacturing pharmaceutical companies expressed conflicting views on Orange Book listing issues. Only IPO further proposed substantial revisions to Form 3542.

FDA's stance on Orange Book patent listings could have a material impact on both brand and generic pharmaceutical companies because any changes could affect patent litigation and timing of generic entry.

Finnegan will continue to monitor and report developments around Orange Book modernization.


1 See FDA In Brief: FDA Takes Actions to Enhance Utility of the Orange Book (May 29, 2020), available at Docket FDA-2020-N-1069 received comments from Amutra Levine, Academy of Managed Care Pharmacy (AMCP), American Pharmacists Assn., Association for Accessible Medicines (AAM), Cigna, Fresenius, National Health Law Program, Purdue Pharma, Vifor Pharma, Teva Pharmaceuticals USA, Inc., Texas Society of Health-System Pharmacists, and Vizient, Inc.

2 Docket FDA 2020-N-1127 received comments from Civica Inc., Apotex Inc., Association for Accessible Medicines (AAM), Teva Pharmaceuticals USA, Inc., Wolters Kluwer, Biotechnology Innovation Organization (BIO), Intellectual Property Owners Association (IPO), Novo Nordisk, Michael Carrier/Rutgers Law School, Karl Racine, Mylan, Knowledge Ecology International (KEI), Christopher Morten/NY Univ. School of Law, Sanofi, Walter Jump, Pharmaceutical Research and Manufacturers of America (PhRMA), and Epstein Becker & Green, P.C.

3. PhRMA Response

4. BIO Response

5. Sanofi Response

6. Novo Nordisk Response

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